They weren't actually 0 for 5, but they might as well have been...
The real problem was they didn't create a dosing system that replicated the results in their tech. They didn't do enough Phase I work (rushed by VCs and big investors) to understand variable PK of each component in humans, match that PK to the AUC concentrations that their machines identified, and then create an original compound that would create those AUCs reliably in patients.
They bragged their system allowed them to esentially bypass Phase I because they were using already approved drugs. On the contrary, they needed to run fairly large Phase I trials to understand AUC inter-patient variability and learn how to dose the drugs together to duplicate the implied AUCs in their machine runs.
Don't get me wrong, I goofed on that aspect of their tech so I'm not trying to shift blame. I wrote quite often about discomfort with them not using a final version of their dosing in the clinicals but didn't draw the line to the AUC issue quickly enough.
Unless otherwise indicated, this is the personal viewpoint of David Miller and not necessarily that of Biotech Stock Research, LLC. We're on Twitter at BiotechStockRsr
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